Baxter CLEARLINK System — Class II medical device recall Z-0607-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-01-13, distributed nationwide. Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solu
| Recall number | Z-0607-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-11-30 |
| Classified | 2016-01-06 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 77,136 units |
| Reason classes | specification failure |
| Lot numbers | GR323907, GR324806, GR326116, GR326645, GR327528, GR328534 |
Product
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: An accessory to transfer a medicinal product from one container to another container.
Reason for recall
Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0607-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.